Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary nephrotic syndrome(PNS) is a group of clinical symptoms caused by a variety of factors, including immune,environmental, genetic, et al. Oral corticosteroids have been to be the preferred drug for the treatment of PNS, but the long-term use of glucocorticoid therapy in clinic often induces some problems such as hormone dependent and hormone resistance, as well as severe side effects which act as a threat to the patients' health. Besides, patients with proteinuria long-term not control often behave faster progression into chronic renal failure, leading to poor prognosis. In renal diseases, Rituximab ( RTX) is often used in the treatment of refractory nephropathy, such as hormone dependent nephrotic syndrome, hormone resistance nephrotic syndrome, frequency recurrence nephrotic syndrome, which shows exciting effects in delaying the development of the disease.At present, mesenchymal stem cells ( MSCs) has been used as a research hotspot to repair the tissue damage of chronic kidney disease, and it also behaves certain effects. The purpose of this study is to seek a more targeted treatment, more precise curative effect and more feasibility treatment for PNS(CKD3-4),so as to delay or reverse the disease and improve the quality of life of patients with CKD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Rituximab

Criteria

Gender-Definition: Physical gender of individuals who may participate in the protocol. Select one-Both: both female and male participants are being studied.

Age Limits-Minimum Age( Definition: Minimum age of participants. ); Maximum Age (Definition: Maximum age of participants).

Accepts Healthy Volunteers?-Definition: Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.

Eligibility Criteria-Definition: Summary criteria for participant selection. The preferred format includes lists of inclusion and exclusion criteria as shown below.

Inclusion Criteria: A. Nephrotic syndrome(urine protein > 3.5g/d and serum albumin < 30g/L）； B. 3-4 stage of CKD [glomerular filtration rate 15-59 ml/ (min ·1.73m²)]； C. Age should be 18-65 years old； D. Accept treatment and signe informed consent voluntarily.

• Exclusion Criteria:A. Secondary nephrotic syndrome such as systemic lupus erythematosis nephritis, anaphylactic purpura nephritis and diabetic nephropathy and so on； B. Complications like severe infection, cardiovascular diseases, severe heart and lung as well as liver complications； C. Dialysis is extremely urgent； D. Obstructive urinary tract diseases； E. Creatinine rises more than 30% of the based value in nearly 3 months； F. Pregnancy or in lactation； G. Any other conditions that researchers consider not suitable to participate in this trial.

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